Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1698—Blood oxygenators with or without heat-exchangers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
  • B01D63/02—Hollow fibre modules
  • B01D63/04—Hollow fibre modules comprising multiple hollow fibre assemblies
  • B01D63/043—Hollow fibre modules comprising multiple hollow fibre assemblies with separate tube sheets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2209/00—Ancillary equipment
  • A61M2209/08—Supports for equipment
  • A61M2209/088—Supports for equipment on the body

Definitions

• the invention relates to a device for the treatment of a biological fluid according to the preamble of the independent claim and in particular to a device having a chamber which is intended to receive the biological fluid, and a gas exchange medium.
• It may be a gassing or degassing, in which one or more gases can pass from one medium to another medium, or a gas exchange device, which allows the exchange of one or more gases between two media.
• gases find application in chemistry, biotechnology and medicine.
• An important use in medicine is the enrichment of a biological fluid, in particular of blood, with oxygen and / or the removal of carbon dioxide from the liquid, especially blood.
• measures are, for example, in the treatment of various lung diseases necessary.
• Such measures may continue to be used e.g. also be necessary in acute lung failure, as well as to replace the lungs during their circumvention with an extracorporeal circulation, to varying degrees in the mechanical cardiac support and to allow to operate in the recumbent heart.
• a blood gas exchanger often referred to as an oxygenator or artificial lung, is used either for full, transient lung function delivery during open heart surgery or as full or partial, long-term lung support for the intensive care unit.
• the main function of such a blood gas exchanger is the delivery of oxygen to the blood (oxygenation) and the absorption of carbon dioxide from the blood (decarboxylation).
• the home exchange takes place, for example, by means of hollow-fiber membranes, which are encased in an extracorporeal gas exchanger of blood, while at the same time oxygen-rich or low-carbon-dioxide gas is passed through the interior of the fiber.
• oxygen or carbon dioxide can in each case diffuse in the opposite direction through a semipermeable membrane, typically a gas-permeable membrane.
• the fibers can be obtained commercially and are delivered, for example, in quadrilateral fiber mats or wound on coils as a single fiber.
• the individual fiber mats are stacked in a crosswise manner, resulting in a parallelepiped, in particular a cubic, packet-shaped fiber bundle.
• the fiber bundle is delimited by two covers, which contain the Anströmgeometrie, and by a potting compound to the outside.
• the lids are placed below and above the fiber bundle.
• the Four sides of the fiber bundle are successively potted on a centrifuge side by side and thus connected to the lids.
• Commercially available gas exchangers produced in this manner also have a corresponding cubic cavity in which the fibers are embedded and circulated by the blood. In general, these gas exchangers are supplied at one of the four corners of the fiber bundle or the cavity.
• connections for the blood-carrying hoses are oriented orthogonally to the covers of the gas exchanger.
• the use of these gas exchangers is limited to stationary applications in which the patient - awake or sedated - lies in bed. Since patients with chronic lung diseases, which rely on one of these known gas exchangers, are thus severely restricted in their mobility, not only the quality of life of the patients is considerably reduced. Even modern therapeutic approaches that seek to mobilize patients are not feasible.
• the object of the present invention is to provide an improved device for the treatment of a biological fluid which solves at least one of the disadvantages of the known systems and which provides a more space-saving gas exchanger, in particular also for a mobile application of the gas exchange. schers.
• a biological fluid treatment apparatus comprising a housing having at least a first cavity forming chamber and a gas exchange means at least partially disposed in the first chamber.
• the first chamber is intended for receiving a liquid to be treated, in particular a biological fluid, such as blood.
• An inlet section for introducing the liquid to be treated into the first chamber is formed on a surface of the housing, which is also referred to below as an inlet surface. According to the invention, the inlet section is formed at an acute angle relative to the inlet surface of the housing on which the inlet section is formed.
• the device according to the invention may comprise as a gas exchange means a second, at least partially formed in the first chamber chamber or form a second chamber.
• the second chamber is intended to receive a first fluid, in particular a first gas.
• the second chamber may be formed by at least one semi-permeable membrane separated from the first chamber.
• the semi-permeable membrane is a gas permeable and liquid impermeable membrane.
• the membrane can serve, for example, a transfer of at least one predeterminable type of molecule between the first and second chambers. The transfer can take place from the first chamber to the second chamber and / or from the second chamber to the first chamber. It can also be provided a plurality of first and / or second chambers.
• semipermeable is to be understood as meaning that the wall is partially permeable, permeability being intended for predetermined molecules, in particular for special gas molecules such as oxygen or carbon dioxide selective permeability to specific, predeterminable molecules or compounds.
• the gas exchange agent in particular the second chamber, may be configured and arranged such that the gas exchange agent is delimited from the at least one gas permeable and liquid impermeable membrane and such that a biological fluid provided in the first chamber, the Gas exchange agent can at least partially surround or flow around.
• the second chamber As far as the following is referred to as a "second chamber", this is only to facilitate understanding of the present invention, but the second chamber is to be understood as forming part of certain more specific embodiments of the gas exchange means the invention allow a gas exchange between a liquid to be treated, such as a biological fluid such as blood, and a necessary for gas exchange fluid.
• a liquid to be treated such as a biological fluid such as blood
• the membrane between the first chamber and the gas exchange medium is typically semi-permeable or semi-permeable and normally has pores whose size dictates the function and effect of the particular membrane.
• each membrane may on the one hand be a porous membrane, ie a membrane which has discrete pores.
• the membrane can be a homogeneous solubility membrane without discrete pores, in which the mass transport through Solution of the permeate (eg of the gas) takes place in the polymer and the separation takes place due to different solubilities in the polymer.
• the membrane is a non-porous permeable membrane.
• gas exchange between the fluid in the gas exchange means and the biological fluid in the first chamber may be allowed.
• Gas exchange may be subject to convective and diffusive mass transfer.
• the gas exchange is diffusive and is determined by the difference in gas concentration on both sides of the membrane.
• the biologic fluid handling apparatus of the present invention through the angled arrangement of the inlet section relative to the surface of the housing, may allow for a more space-efficient introduction of the fluid into the first chamber as compared to the orthogonal ports commonly used in the known stationary systems.
• a tangential flow and supply and discharge of the liquid can take place, so that supply and discharge lines can be guided in almost the same plane in which the housing or the housing surface is also formed. This can in particular enable a transport close or directly on the body, for example of a patient. This can increase a mobility of the device and consequently of a user.
• the first chamber is configured as a flow chamber and has an inlet and an outlet separate from the inlet.
• the second chamber may also be formed as a flow chamber.
• the first chamber may preferably be intended to flow in one direction against or transverse to the direction of flow of the second chamber.
• the gas exchange means in particular the second chamber, is subdivided into a plurality of subchambers, so that the device comprises a plurality of second chambers intended to receive a gas and separated from the first chamber by a gas-permeable and liquid-impermeable membrane.
• the plurality of second chambers are within the first chamber or are substantially surrounded by the first chamber.
• the second chambers have an elongated and preferably substantially cylindrical structure, which has one or more continuous cavities in cross-section.
• a wall of the second chambers delimiting the cross-section at least partially forms the gas-permeable and liquid-impermeable membrane.
• the plurality of second chambers are arranged in one or more rows next to one another and preferably also at a distance from one another. Furthermore, the plurality of second chambers may be arranged in multiple layers.
• the second chambers are formed, for example, as a hollow body, preferably as hollow fibers, so that the wall of each hollow body or each hollow fiber forms the gas-permeable and liquid-impermeable membrane.
• the distance between the plurality of second chambers arranged next to one another is preferably in the range from 50 ⁇ m to 1 cm, more preferably in the range from 100 ⁇ m to 1 mm, and even more preferably in the range from 100 ⁇ m to 500 ⁇ m. This distance can be chosen or set as desired.
• the housing further has an outlet section on a surface, the outlet surface, of the housing for discharging the biological fluid from the device.
• the outlet section can likewise be arranged at an acute angle relative to the surface of the housing.
• the angle which the outlet section assumes against the outlet surface may in particular be the same angle as that which the inlet section assumes against the corresponding inlet surface.
• the angle of the outlet section differs from the angle of the inlet section to the corresponding surface. This may allow for consideration of the anatomy of the wearer or the position of the device on a wearer or in a housing or carrying device, particularly with regard to mobility of a wearer.
• the outlet section may in principle also be provided on the same surface of the housing as the inlet section.
• inlet section and outlet section may vary.
• the inlet and outlet sections can be arranged horizontally next to one another, or vertically above one another.
• both a parallel or an orthogonal arrangement of the outlet section relative to the inlet section is possible.
• the outlet portion is diametrically opposed to the inlet portion.
• the inlet section is arranged at a position which, at a position in which the device according to the invention is commonly used, is located at an upper section of the gas exchange device.
• the outlet section may in this case be formed in particular on a lower section of the device.
• the angle that the inlet portion is relative to the respective inlet surface that is, the inlet angle, and / or the angle that the outlet portion relative to the outlet surface of the housing, So the outlet angle, occupy less than 45 °, preferably less than 25 °, in particular between 1 5 ° - 20 °.
• the inlet section may be formed on the surface of the housing such that a biological fluid conducted through the inlet section may be introduced into the first chamber such that it is introduced into the first chamber at a central region of the gas exchange means, in particular the fiber bundle.
• a central region designates a region of the gas exchange medium or of the fiber bundle which extends in a lateral extension, ie in those directions which essentially span a surface which is parallel to the inlet surface, in the center or in the region of the center of the Fiber bundle is located.
• the supply and / or discharge for the first fluid or further components into the housing can also take place tangentially or at a shallow angle, for example relative to a circumferential surface of the housing. In this way, further space savings for the gas exchange device can be made available.
• the gas exchange means is configured as a fiber bundle defined by a plurality of hollow fibers, which is at least partially disposed in the first chamber.
• the first chamber may have a substantially cylindrical shape.
• a cavity is formed which essentially has a cylindrical shape. This means that the cavity has no corners or unsteady edge areas in the edge areas.
• the gas exchange agent, in particular the fiber bundle may also have a substantially cylindrical form.
• the shape of the gas exchange agent or of the fiber bundle and the shape of the cavity, ie, the inner contour of the first chamber may have mutually matched shapes and dimensions, so that the gas outlet is exchange medium can be arranged as ideally as possible in the cavity of the first chamber.
• An ideal arrangement in this connection would be an arrangement in which the largest possible area of the gas exchange medium flows uniformly around the biological fluid, preferably laminar, and at a substantially constant, uniform flow rate over the entire flow cross section.
• cylindrical fiber bundle can also allow better utilization of the cavity, ie the space available for gas exchange in the first chamber. This can reduce the reliability and durability of the device, for example, by reducing turbulence and consequent degeneration. Such degenerations take place in particular in corner regions of a cubic cavity, resulting in an increased risk of coagulation when using blood as a fluid in the first chamber. The formation of a cylindrical cavity while avoiding such corner areas can reduce this risk.
• Cylindrical fiber bundles are, of course, also suitable in principle for the flow by means of orthogonally arranged inlet sections.
• the gas exchanger may have a pressure transmitter on a side of the first chamber facing the inlet section.
• the diaphragm seal is used to equalize pressure differences in a flow cross section of the biological Liquid.
• the flow cross section of the liquid characterizes the entire area occupied or flows through the liquid or the liquid front in the first chamber.
• biological fluids such as blood
• regions can form in which the flow rate is so greatly reduced that an increased accumulation of liquid constituents forms on the walls, above all also on the membranes to form the gas exchange medium.
• this can impair the function of the gas exchange.
• this can lead to contamination of the liquid when deposited material separates again from the walls.
• a diaphragm seal which can bring about a more uniform distribution of the inflow pressure into the first chamber, can reduce this effect.
• such a diaphragm seal can increase the reliability of the device according to the invention.
• the pressure transmitter may have a substantially oblique plane along which the biological fluid is passed when flowing into the device. This can further reduce the formation of pressure differences and flow separation, ie stationary vortex, can be better avoided.
• At least one of the surfaces of the device is a lid.
• a lid can be designed in particular as a removable lid, so that access to the first chamber or to the gas exchange means, in particular to the second chamber, is made possible in the device.
• the cover is basically arranged in a region upstream of the first and the second chamber.
• the lid can also be connected to or with the second chambers and close them to the outside.
• a pressure transmitter may be provided at least on the lid of the inlet surface on the inside thereof, preferably in the form of an oblique plane.
• Such a diaphragm seal is also referred to as a blood distribution plate.
• a distribution means can be formed in the device, which is designed to distribute the biological fluid in a direction substantially lateral to the flow direction.
• an improved flow of a larger area of the gas exchange agent, in particular a fiber bundle or the second or further chambers, can be achieved.
• the distribution means may also be formed integrally with the pressure transmitter.
• the distributor means starting from a side facing the inlet section, has a channel-like section which opens in the lateral direction in the flow direction of the biological fluid.
• a "lateral direction” represents a direction which extends in substantially the same direction as the inlet surface on which the inlet section is arranged or through which the inlet section is formed
• the inclination may be in a direction corresponding to the angle of the inlet portion to the inlet surface. Allow angles of different angles.
• the distribution means can simultaneously represent an inclined plane in order to improve the liquid to be treated into the first chamber and via the house exchange means.
• the distribution means is inclined from the inlet portion to the first chamber.
• the distributor means may be formed integrally with the pressure transmitter and / or with the inlet section and / or with the lid on the inlet side and / or with the inlet surface of the housing.
• a third chamber can also be formed in a further embodiment of the invention in the first chamber.
• the third chamber may also be formed as part of the gas exchange means.
• the third chamber can be separated from the first chamber by at least one liquid-permeable membrane and serve to withdraw one or more components of the biological fluid. This can provide the device according to the invention Open areas in which specific liquid components are removed from the biological fluid or the liquid are buried.
• the third chamber may also be formed analogously to the second chamber, but in a different arrangement to the second chamber.
• the second and third chambers may each comprise a plurality of layers of a fiber bundle, each consisting of a plurality of parallel arranged hollow fibers.
• the individual layers of the second and third chambers can then be arranged alternately stacked, wherein the hollow fibers of a layer are not aligned parallel to the hollow fibers of an adjacent layer.
• the hollow fibers of a layer may be oriented at right angles to the direction of extension of the hollow fibers of an adjacent layer. In this way, the contact surface of the biological fluid with the second and third chambers can be increased.
• the device according to the invention can be designed as a gas exchanger which can be used in an artificial lung or in a bioreactor. It is thus fundamentally possible to provide a device for the treatment of a biological fluid with different connections and geometrically differently designed gas exchange elements.
• the aim of a device for the treatment of a biological fluid according to the present invention is to deplete a biological fluid, in particular blood, of carbon dioxide or other gases or other, even more complex molecules and / or to enrich it with oxygen or other gases or other molecules. Naturally It is also possible to achieve a depletion of other constituents of the liquid in principle.
• fiber mat is also used here as an example for a gas exchange medium.
• Fiber mat is taken to mean one or more layered structures which may be formed, for example, from hollow fibers which are formed in a mat-like arrangement become. Layered fiber layers, or individual fiber mats, can each be rotated at an angle to form an underlying layer, whereby a round fiber mat arrangement or a round fiber bundle can be created. Depending in particular on the intended use and expierter size fiber mats can generally be composed of several individual fiber layers, soposition len fiber mats, or consist of only a single layer. Such fiber mats are known from the prior art, which in particular have a rectangular basic shape and are in the form of a fiber mat layer.
• Such fiber mat arrangements or fiber bundles have insofar a cuboid shape.
• the problem with such cuboidal fiber mat arrangements can lie in the fact that, assuming a corresponding shape of the cavity in the gas exchange device, ie an equally parallelepipedic cavity, an at least substantially uniform flow can not be ensured. In particular along the edges and in corner portions of the cavity, swirling of the liquid can increasingly occur, which can lead to a degradation of the liquid. The efficiency of the gas exchange in these peripheral areas can thus be reduced.
• a round, preferably circular, cavity in which a parallelepiped or a round gas exchange means, in particular a fiber mat or a fiber mat arrangement, is arranged.
• the contour of the gas exchange medium ideally corresponds to the shape of the cavity, so that the largest possible volume of the cavity can be filled with the gas exchange medium. This can ideally increase the volume in the cavity available for gas exchange.
• the use of a cuboidal fiber mat or fiber mat arrangements in a round cavity may allow edge effects on the wall of the cavity where the Flow rate of the liquid is inevitably minimal, to avoid.
• an improvement in the efficiency of the gas exchange element ie in this case the fiber mat or fiber mat arrangement, can be achieved.
• the shape of the cavity for example for receiving the fiber mat or fiber mat arrangement in the device as well as the shape of the fiber mat or the fiber mat arrangement itself can be round or even circular.
• a "round" shape of the fiber mat or of the fiber mat arrangement or of the cavity can correspond to any shape which has a continuous edge course, that is to say an edge course without the formation of edges and corners.
• a round shape may also include an elliptical design.
• a round shape may also comprise other symmetrical or asymmetrical shapes, for example those shapes which allow an improved flow around the fiber mat or the fiber mat arrangement, generally also the gas exchange means.
• round shape can also be understood, for example, to mean a cavity having rounded corners and edges
• the shape of the gas exchange medium can also vary in a height direction along a cross section of the gas exchange medium, for example
• the forms of the gas exchange medium are therefore not limited and the entirety of the molds can be arranged in a cavity of a gas exchange device, as long as the necessary connections are present and the specifics see Dimensions of the cavity and the gas exchange means allow insertion of the gas exchange agent in the cavity.
• the shapes of the cavity of the first chamber and the gas exchange agent can also vary from each other.
• a connection for the supply of the biological fluid into the gas exchange section can also be arranged orthogonal to the surface.
• This can be, for example then the Fal l be when the gas exchange means is inclined relative to the surface of the gas exchange device, in particular inclined at an acute angle.
• the specific form of the gas exchange agent itself may already cause an inclined inflow of the liquid relative to the gas exchange agent, for example if an inhomogeneous height expansion of the gas exchange agent results in an oblique plane on the surface of the gas exchange agent.
• the cavity for receiving the gas exchange agent in an inclined position to the surface of the gas exchange device, on which the connection to the inflow of the liquid is formed is arranged.
• the housing has a prismatic shape, in which the side surfaces of the housing are formed as prism surfaces, the Habitus of the housing is recessed, in particular flat and wherein a Blüleineinut is arranged on an inlet surface designed as an end face of the prismatic housing.
• the device for the treatment of a biological fluid BiI a particular prismatic housing having a first, a cavity bi ldenden chamber, which is for receiving the liquid to be treated
• at least one gas exchange means the at least tei lweise in the first chamber is arranged, wherein formed in a surface of the housing, in particular a cover of the housing, an inlet portion for the inlet of the liquid to be treated in the first chamber.
• the inlet section extends at an acute angle of attack relative to the surface of the fiber bundle.
• the angle of attack is less than 45 °, preferably less than 25 °, particularly preferably has a value of 5 ° to 20 ° and in particular at 1 5 ° L iegt. It is furthermore advantageous if flow baffles are arranged on both sides of the channel-like section, which have an opposite slope to the slope. le of the channel-like portion, so that intersect by a defined by the channel-like portion first axis and a through the flow guide surfaces and defined second axis at an acute angle of preferably 5 ° to 20 °. Through the two flow guide surfaces and a vortex-free distribution of the incoming fluid flow is achieved. In the case where the introduced fluid is blood, it effectively prevents blood coagulation (clumping) and blood damage (hemolysis). It is achieved a very good permanent gas exchange efficiency based on gas exchange surface.
• the inflow can also take place orthogonally relative to the inlet surface of the housing and / or relative to the gas exchange medium itself, in particular a fiber mat or a fiber mat arrangement.
• An orientation of the gas exchange agent in the cavity can also be an inclined orientation, for example with respect to the inlet surface.
• FIG. 5 shows: a schematic representation of a section of a fiber bundle for a device according to an embodiment of the invention, a schematic representation of a device according to the invention according to an embodiment of the invention, an enlarged cross-sectional view of a connector for a device according to an embodiment of the invention, a schematic representation of a lid for a device According to one embodiment of the invention, a schematic representation of another lid for a device according to the invention according to another embodiment of the invention, a cross-sectional view of the lid of FIG. 5 in a section along the line Vl-Vl in Fig. 5, a perspective cross-sectional view of the lid from Fig. 5 in a section along the line VII-VII in Fig. 5th
• Figure 1 shows a better understanding of the present invention, an example of the construction of a gas exchange agent, here in the form of a multilayer fiber bundle composed of two types of layers in the form of differently oriented fiber mats 1 9 and 21st 1 shows, for the basic understanding of the present invention, only a schematic view of the fiber bundle 118 with the fiber mats 19, 21 in a kind of exploded view of the layers.
• Figure 1 leaves Due to the schematic nature of a Tei area of the fiber bundle 1 8 no conclusions about the actual form of a fiber bundle, as it should be used in a device according to the invention, in particular not regarding the shape, proportions or formation of fiber bundle layers or their specific properties.
• an arrangement of fiber mats which is also referred to as a fiber bundle for the purpose of description, is selected from the individual fiber layers, also referred to as fiber mats.
• the fiber bundle 18 has a surface 8 defined by a first fiber mat 19, 21.
• a device 1 according to the invention has a housing 2 which encloses a first chamber 3 and partially defined.
• the first chamber 3 is for receiving a biological fluid, e.g. Blood, determined and is in the illustrated embodiment as a flow-through chamber.
• the biological fluid or blood flows in the direction shown by the arrows 4 through an inlet surface 5 in the housing 2 into the first chamber 3 and leaves the first chamber 3 through an opposite outlet surface 6.
• the housing 2 preferably consists of one for the biological fluid chemically unreacted plastic, such. As polyethylene or polyurethane.
• the housing 2 has a prismatic shape in which the side surfaces are formed as prism surfaces 4, the base surface as the outlet surface 6 and the end surface as the inlet surface 5.
• the habit of the housing 2 is shallow, i. the height of the housing 2 between the outlet surface 6 and the inlet surface 5 is smaller than its lateral extent transverse to its height.
• the surface 8 of the fiber bundle 1 8 extends substantially paral lel to a plane defined by the inlet surface 5 level.
• the device 1 has a tubular second chamber 7, which extends through the first chamber 3 and is surrounded by the first chamber 3 in wesentl ichen.
• the second chamber 7 is not recognizable in FIG.
• a tubular wall bounds or surrounds the cavity of the second chamber 7 Wall is relatively thin and is preferably made of a plastic and serves as a support material for an outer layer, which forms a gas-permeable and liquid-impermeable membrane 9 together with the wall.
• the second chamber 7 is intended to contain and direct a fluid.
• the fluid is a gas, for example ambient air, compressed air, an oxygen-enriched gas mixture or highly enriched or pure oxygen.
• the tubular wall allows a transfer of gas molecules between the first chamber 3 and the second chamber 7.
• the membrane 9 forms a separation or contact surface, at which an intimate contact between the molecular components of the blood and the in the second chamber contained medium or can take place.
• the gas-permeable and liquid-impermeable membrane 9 is preferably selectively permeable to carbon dioxide and / or oxygen.
• the described invention is used to effect an oxygenation, ie an oxygen enrichment, in the biological fluid.
• an oxygenation ie an oxygen enrichment
• a suitable gas is selected, for example, oxygen-enriched air or low-carbon air to effect gas exchange with the biological fluid.
• the selected gas flows in the direction shown by the arrow 1 0 in Figure 1 through an inlet 1 1 in the second chamber 7 and leaves the second chamber 7 through an opposite outlet 1 2.
• the gas flowing through the second chamber 7 Can pass in part through the gas-permeable and liquid-impermeable membrane 9 in the flowing through the first chamber 3 liquid.
• a gas portion dissolved in the liquid in the chamber 3 can pass through the membrane 9 into the second chamber 7. This can, in the Case that the biological fluid is blood, an enrichment of the blood with oxygen or a depletion of the blood of carbon dioxide take place. In this way, a so-called ventilation or lung replacement procedure takes place on the membrane 9.
• a pressure Pi and / or the flow of the biological fluid or of the blood in the first chamber 3 can be selected or adjusted in relation to the pressure P 2 and / or to the flow of the oxygen flowing through the second chamber 7.
• a desired transfer of oxygen into the liquid and / or carbon dioxide from the liquid can be achieved.
• the blood can be conveyed for example by means of a pump (not shown) through the first chamber 3 or it can also flow through the first chamber 3 only under the pressure of the circulatory system of the patient.
• the device 1 may further comprise, in particular embodiments, a tubular third chamber 13 which, like the second chamber, extends through the first chamber 3 and is substantially surrounded by the first chamber 3.
• a tubular wall 14, which encloses the cavity of the third chamber 13, is relatively thin and is preferably made of a plastic.
• the wall 14 serves as a support material for an outer layer.
• the third chamber is a chamber independent of the second chamber 7, which has a gas-permeable, liquid-impermeable membrane 15 which is permeable to the same or other or additional gases as the membrane 9 between the first chamber 3 and the second chamber 7. So can For example, a second independent gas supply may be coupled to the device or, if necessary, additional gases may be fed into the device or a depletion rate of gases from the biological fluid increased.
• the third chamber 13 together with the wall 14 can also form a liquid-permeable membrane 15, so that the tubular wall 14 enables a transfer of liquid components between the first chamber 3 and the third chamber 13.
• this membrane 1 5 forms a separation or contact surface, which serves to remove one or more liquid components of the biological fluid.
• the wall between the first chamber 3 and the second chamber 7 constitutes a liquid-permeable wall 9.
• the liquid-permeable membrane 15 located between the first and third chambers may then act as a filter via which smaller molecules such as water are pressed from a biological fluid, for example blood, and larger molecules such as proteins and blood cells are retained.
• the gas exchange means of the device according to the invention can have one or more second chambers. It is further understood that the structure shown in Figure 1 of a gas exchange means in the form of one or more fiber bundles may indeed be advantageous for the invention or for developments of the invention. However, gas exchange agents with a different layer structure or without a layer structure are also conceivable within the scope of the invention, for example in the form of porous structures. In this respect, the illustration in Figure 1 merely represents an exemplary gas exchange means in the form of a fiber bundle for certain embodiments of the present invention. In one embodiment of the present invention, as shown in Figure 1, the second chamber 7 and the third chamber 1, respectively 3 a plurality of tubular shaped hollow fibers, as will be explained below.
• the housing 2 encloses or at least partially defines the first chamber 3.
• the first chamber 3 is intended to receive a biological fluid, such as blood, and is designed as a flow chamber.
• the first chamber 3 may also correspond to a receptacle for receiving the second and / or third chamber which is inserted into the housing and corresponds to the opening in the housing.
• first chamber 3 and the second chamber 7 or further chambers 13 are provided as an interconnected, sterile closed system.
• a housing 2a the first chamber would be inserted into a corresponding opening of the housing 2 of the gas exchange device.
• a fiber bundle can also be inserted into the housing 2 of the gas exchange device 1, with the inner wall of an opening of the gas exchange device 1 or the inner wall of an insert in this opening defining the first chamber 3.
• the device 1 as shown in Figure 1 has a plurality of tubular second chambers 7 arranged side by side in rows.
• the second chambers 7, ie the gas exchange means, extend in parallel through the first chamber 3 and are essentially surrounded by the first chamber 3.
• the rohrför--shaped walls which surround the cavities of the second chambers 7, may be in the form of hollow fibers made of polymethylpentene (PMP, also under the brand name TPX ® known), for example foamed TPX be formed. In other embodiments, other materials may be used in the same way.
• PMP polymethylpentene
• TPX ® polymethylpentene
• other materials may be used in the same way.
• the walls of the second chambers 7 and their outer surfaces or layers form gas-permeable and liquid-impermeable membranes 9, so that a transfer of gas molecules between the first chamber 3 and the second chambers 7 located inside the hollow fibers is made possible.
• the second chambers 7 are intended to receive a gas such as oxygen or ambient air and are also designed as flow chambers.
• the gas-permeable and liquid-impermeable membranes 9 may be selectively permeable to oxygen and / or carbon dioxide.
• the selected gas flows in the device shown in Figure 1 in the direction shown by the arrow 10 through inlets 1 1 in the second chambers 7 and leaves the second chambers 7 through opposite outlets 1 2.
• the hollow fibers which are arranged next to one another in a row / plane and which form the second chambers 7, for example TPX fibers, are connected to one another by warp threads 18 in a textile-technical process. This results in a kind of fiber mat 1 9 with defined distances D 2 between the fibers. This distance D 2 between the fibers serves to ensure that the blood flowing through the first chamber 3 flows through the mat 1 9 and thus can reach maximum contact with the contact surfaces of the membranes 9.
• the individual hollow fibers have an outer diameter in the range of 1 00 ⁇ to 1 mm, preferably in the range of 200 pm to 600 pm, (eg about 400 ⁇ ), and they are in each row or level next to each other with a distance D 2 in the range of 1 00 ⁇ to 500 ⁇ arranged.
• This distance can be chosen arbitrarily. Therefore, it is clear that a plurality of fibers can be juxtaposed and processed into mats.
• the dimensions of the fiber membrane mat 1 9 are, for example, about 1 0 cm x 1 5 cm.
• the fiber mats hereinafter also referred to as fiber membrane plates
• fiber membrane plates have a round shape to correspond to a cylindrical cavity in the housing.
• these fiber Membrane plates Arrangements of several superimposed fiber mats.
• cuboid or cubic fiber membrane plates are used with a cylindrical cavity, or that round, or substantially cylindrical, fiber membrane plates are used with a cubic or cuboid cavity of the device according to the invention.
• mats or fiber mats 19, 21 these mats 19 can subsequently be further processed in which they are stacked on top of one another.
• FIG 1 only two layers or mats 1 9 of the second, parallel chambers 7 are shown and these are stacked. However, it is understood by those skilled in the art that a plurality of such mats 1 9 can be provided one above the other in the first chamber 3.
• the ends of the fibers forming the second chambers 7 are bundled together. In this way, the individual inlets can be fed via a common inlet 11 with gas, for example ambient air or oxygen. Analogously, the individual outlets go into a common outlet 12.
• connection of the fibers of the same orientation preferably takes place via a casting process, eg with polyurethane
• the ends of the fibers are coated with liquid plastic
• slicing is then carried out from the outside until the interior of the fibers is opened, thus achieving a common supply of fluid to the individual fibers or chambers.
• the device 1 in Figure 1 a plurality of tubular third chambers 1 3, which extend as well as the second chambers 7 in parallel through the first chamber 3 and are surrounded by the first chamber 3 substantially.
• the hollow fibers may be formed as well as the hollow fibers of the mats 1 9 described above, it is also possible in particular embodiments, that the tubular walls 14 which enclose the cavities of the third chambers 1 3, in the form of hollow fibers of polyethersulfone (PES) are formed.
• the walls 14 of the hollow fibers with their outer surfaces form liquid-permeable membranes 1 5, which can enable a transfer of liquid components between the first chamber 3 and located in the interior of the hollow fibers, third chambers 1 3.
• the membranes can form 1 5 separation or contact surfaces, which serve to withdraw one or more components of the biological fluid.
• the hollow fibers of the first mats 19 are connected to one another by warp yarns 20 in a textile-technical process.
• This distance D 3 between the fibers also serves to ensure that the liquid flowing through the first chamber 3, in particular blood, flows through the mat 21 and thus can reach maximum contact with the surface of the membranes 15.
• FIG 1 only two layers or mats 21 of third chambers 1 3 are shown and these are shown as stacked layers 21.
• the individual fibers in this embodiment have an outer diameter in the range of 100 ⁇ to 1 mm, preferably in the range of 200 ⁇ ⁇ to 600 ⁇ , and they are in each row or level side by side with a distance D preferably in the range of 1 00 ⁇ to 500 ⁇ arranged.
• a plurality of fibers can therefore be juxtaposed and processed into mats 21.
• the dimensions of each fiber membrane mat 21 are also about 10 cm x 1 5 cm, whereby 21 different, in particular round, forms are possible analogous to the above statements for such multilayer fiber membrane mats 21.
• the processing of the individual fiber membrane mats 21 takes place, moreover, as for the fiber membrane mats 19, as described in detail above.
• Such fibers or fiber mats are known in principle from WO 201 0/091 867, for example.
• the mats or fiber mats 19, 21 are preferably placed directly on top of each other, so that they are in contact with each other.
• the layers or mats 1 9, 21 are shown far apart in egg ner explosion Darstel development to allow a clearer explanation of the invention.
• the device 1 is designed as an artificial lung, which is illustrated schematically in FIG.
• the housing 2 of the device 1 is formed essentially rectangular parallelepiped with rounded side edges.
• an inlet section 31 in the form of a connector is formed in a corner region of the inlet surface 5.
• a feed line 33 is formed on a side facing away from the housing 2 of the inlet portion 31, a feed line 33 is formed.
• an outlet portion 41 having a drain 43 is provided on the outlet surface 6 of the housing 2. Due to the perspective depicting development of Figure 2, the outlet surface 6 in the figure, however, can not be seen.
• a further connection 35 is additionally provided on or adjacent to the inlet surface 5.
• the connection 35 branches in particular from a surface 4 of the housing 2 from.
• connection 35 may have various functions.
• the connection 35 can serve for the gas supply of the gas exchange medium, that is to say essentially the second chamber 7 or the third chamber 13 in accordance with the embodiment of the gas exchange means shown in FIG.
• a fluid removal can take place by means of the connection 35, in particular in a fluid circulation system with a plurality of connections 35, as shown in FIG.
• FIG. 3 shows an inlet section 31 for a device 1 according to the invention.
• the inlet portion 31 is formed on the inlet surface 5 of the housing 2.
• a connection section 32 is provided on a side of the inlet section 31 facing away from the inlet surface 5.
• the connection section 32 serves for the connection of the inlet section 31 with a fluid supply, that is, for example, a hose as a supply line 33.
• the inlet section serves in particular for the supply of a biological fluid, such as blood.
• an opening 36 is provided, which forms the inlet of the liquid in the first chamber 3 - not shown in Figure 3 -.
• the inlet portion is formed and arranged at an acute angle relative to the inlet surface 5.
• this inlet angle is approximately 1.5 °.
• the inlet angle may be varied, the inlet angle preferably being less than 45 °, more preferably less than 25 °, and more preferably between 1 5 ° -20 °. Due to the parallelism of the surface 8 of the Faserbün- dels 1 8 arranged in the housing 2 to the inlet surface 5 or to the plane defined by this, the inlet portion 31 extends at an acute angle of attack ⁇ relative to the surface 8 of the fiber bundle 1 8.
• This flow angle ⁇ is preferably less than 45 °, more preferably less than 25 °, and in particular has a value of 5 ° to 20 °.
• the angle of attack ⁇ has a value of 1 5 °. In this way, a tangential flow with the biological fluid is made possible. In addition, a tangential supply and discharge guidance can be made possible in this way. This, in turn, may allow installation in a compact format, for example in a portable device.
• FIG. 4 shows a cover 50 of the device according to the invention.
• the cover 50 is in particular designed such that it can be arranged below the opening 36 shown in FIG. 3, so that the liquid introduced through the inlet section 31 is directed onto the cover 50.
• the cover 50 has a channel-like section 51.
• “Channel-like” is understood to mean that the channel-like section 51 represents a depression in the cover 50, which predetermines a direction of flow of the liquid conducted onto the cover 50.
• the arrow in FIG indicates a flow direction of the introduced liquid along the lid 50.
• the channel-like section 51 has a first end 52 and a second end 53.
• the channel-like portion 51 is formed to expand in the flow direction from the first end 52 to the second end 53 thereof. This leads to a distribution of the introduced liquid over a larger area and thus allows a more homogeneous flow of the lid 50 downstream components, ie substantially the first chamber 3 with the gas exchange means.
• the cover 50 or the channel-like section 51 of the cover 50 is preferably designed such that the channel-like section 51 expands at an angle of between 1 0 ° -20 °.
• the clamping angle ie the angle by which the channel-like section 51 expands according to this definition, is 14 °.
• the angle that the individual legs of the channel-like section 51 include is twice the clamping angle, ie 28 ° in the embodiment shown. While in the embodiments shown in FIGS. 3 and 4, the inlet section 31 and the cover 50 are designed as individual components, it is conceivable that the inlet section 31 is also formed integrally with the cover 50.
• the lid 50 could be arranged, for example, in the opening 36 of the inlet surface 5 so that the liquid introduced through the inlet portion 31 is introduced directly into the chamber 3.
• the lid may also have an inclined plane which, for example, following the inclination of the inlet section, leads from the egg nlassober Assembly 5 through the opening 36 into the first chamber.
• the cover is at the same time a diaphragm seal component due to the widening channel, since the inflowing fluid is distributed over a larger area and thus the flow pressure is reduced.
• the lid according to the embodiment according to FIG. 4 also represents a distribution means for the inflowing liquid.
• the lid 50 may also be formed separately from a diaphragm seal or from a distributor means, for example as a cover of the inlet surface 5 on the outside of the inlet surface 5 or on the inside of the inlet surface 5.
• a separate Diaphragm seal and / or a separate distribution means may be provided in the device.
• FIGS. 5 to 7 show an alternative cover 50 'of the device according to the invention.
• the lid 50 ' is either designed so that it can be arranged below the opening 36 shown in FIG. 3, so that the liquid introduced through the inlet section 31 is directed onto the lid 50 ' , or it is designed to cover the whole Surface / inlet surface 5 of the prismatic housing 2 forms.
• the cover 50 ' once again has a channel-like section 51 ' .
• “Channel-like” is understood to mean that the channel-like section 51 'represents a bulge in the cover 50 ' , which defines a flow direction of the in the lid 50 ' introduced liquid pretends.
• FIG. 5 identifies an inflow direction of a liquid introduced into the cover 50 ' and the arrows 61 .1 and 61 .2 (in FIG. 5) and the arrows 62.1 to 62.3 (FIGS. 6 and 7) the further flow course of the flow inflowing liquid between the lid 50 ' and the underlying, inside the housing l hegenden fiber bundle, which is indicated in Figures 5 to 7 by the position of its surface 8.
• the channel-like portion 51 'of the inlet portion 31 ' is arranged at a sharp inlet angle relative to the inlet surface 5, as shown particularly in FIG. 6.
• this inlet angle is approximately 1.5 °.
• the inlet angle may be varied, the inlet angle preferably being less than 45 °, more preferably less than 25 °, and more preferably between 1 5 ° -20 °.
• the channel-like portion 50 'of the inlet portion 31 ' extends at an acute angle of attack ⁇ relative to the surface 8 of the fiber bundle
• This angle of incidence ⁇ is preferably less than 45 °, more preferably less than 25 °, and in particular has a value of 5 ° to 20 °.
• the angle of attack ⁇ has a value of 1 5 °.
• each flow baffles 54.1 and 54.2 On both sides of the channel-like portion 50 ' are each flow baffles 54.1 and 54.2, which have an opposite slope (arrow 62.2 in Fig. 6) to the Gelig le (arrow 62.3 in Fig. 6) of the channel-like portion 50 ' , so in that a first axis A1 defined by the channel-like section 50 ' and a second axis A2 defined by the flow-guiding surfaces 54.1 and 54.2 intersect at an acute angle ⁇ of approximately 5 ° to 20 °.
• the acute angle ß has a value of 1 6.35 °.
• the slope of the two flow guide surfaces 54.1 and 54.2 (arrow 62.2 in FIG. 6) is preferably 1 ° to 5 °.
• the incline (which corresponds to the angle the flow guide surfaces 54.1 and 54.2 to the surface 8 of the fiber bundle 1 8 corresponds) 1, 35 °.
• the device according to the invention only a decarboxylation without simultaneous oxygenation should be carried out with the device according to the invention. Since it is a fundamental endeavor to keep extracorporeal volume flows as low as possible, for example when withdrawing and returning blood into a body, the volume flows for such CO 2 removal systems are typically in the range below 2l / min, preferably at approximately 0 , 3-1 l / min. In order to ensure a sufficient flow and an effective gas exchange at such low flow rates, the dimensioning of the fiber bundle or the cavity is crucial.

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• Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Heart & Thoracic Surgery (AREA)
• Emergency Medicine (AREA)
• Anesthesiology (AREA)
• Public Health (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Veterinary Medicine (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
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• External Artificial Organs (AREA)
• Separation Using Semi-Permeable Membranes (AREA)

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• 2015
  • 2015-05-07 EP EP15001369.6A patent/EP3090768A1/de not_active Withdrawn
• 2016
  • 2016-05-09 EP EP16724285.8A patent/EP3291855B1/de active Active
  • 2016-05-09 CN CN201680032708.2A patent/CN107666921B/zh active Active
  • 2016-05-09 US US15/572,294 patent/US10610629B2/en active Active
  • 2016-05-09 WO PCT/EP2016/000750 patent/WO2016177476A1/de active Application Filing
  • 2016-05-09 JP JP2017558012A patent/JP6825178B2/ja active Active

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